Development Of The Reporting Guideline For TCM Complex Interventions

ObjectiveTo Develop the reporting guideline of complex interventions in TCM, for improving the quality of report.The quality assessment of complex interventions’ articles is to understand the status and deficits of complex interventions in TCM.MethodThis study can be divided into two stages, the first is to develop the reporting guideline for complex interventions’study of TCM. Secondly, using the reporting guideline to assess the quality of complex interventions’ articles in TCM.1.Development of the reporting guideline:By summarizing the results of previous studies, and thinking about the the reality of clinical research, according to the procedure of clinical research, identify the key points. First set up the framework simply report. Experts advice in three installments, with the first round of a small range of consulting, using interviews, reaching the perfect framework for the role of entry; second round of experts advice in the form of group meetings, selected seven experts to discuss and give advices; the third round of the supplemental consultation, by mail to the role of refined way of entry. By finishing the previous literature review and three expert advices, the reporting guideline was came into being.2.The quality assessment of complex interventions’articles in TCM: Selected complex interventions’articles published in Chinese Journal Integrated Traditional and Western Medicine, Journal of Traditional Chinese Medicine in2007-2012by hand. Evaluation tools includes the CONSORT FOR TCM standards and the reporting guideline for complex interventions in TCM which we developed. The two used together to achieve mutually complementary role is to evaluate better and more targeted. This process consists of two trained personnel independently evaluated one by one, unified verification, in case the differences, the two men agreed through discussion. If can not reach agreement, decided by expert arbitration. Use the results of statistical counting one by one, while the percentage and Kappa values is calculated. Result1.Complete the development of "The reporting guideline for complex interventions in TCM". The main aspects of the entire report specification TCM clinical intervention studies around the complex background, the need for intervention based on the elements of choice, choose the overall design of the interventions, pre-trial,trial protocol design, evaluation, and analysis of mechanism of action and so on. The reporting guideline has11items in total.2.The reporting quality assessment of articles:354literatures involved, only37reports of the literature described the basis for the formation of a complex intervention programs, the intervention relationship between elements of the interaction were discussed in118literatures, and the remaining236articles not covered by this content.Containing312RCTs,32non-randomized concurrent control trials, and8cohort studies. Most complex interventions were composed of traditional and western medicines, as many as207pieces. Only37of them have solid evidences to prove the scientificity of complex interventions. In the respect of explaining the interactions between different components, including synergistic effect, complementary effect, attenuation and synergistic effect which60,27,31papers mentioned separately, others were unconcerned. Otherwise, only225papers carried out the strict randomization,29and27papers implemented the allocation concealment and blind method. Only four of them had foundation of Sample size determination. Most of them neglected flow diagram, intention to treat (ITT) and ethical approval, only0,7,9papers involved separately.ConclusionFirst proposed a complex intervention for TCM clinical research literature reporting practices, including the report of such research should focus on relevant content that can be used to improve the quality of traditional Chinese medicine complex interventions research, the current major issues clearly complex clinical trials and interventions reported in the literature exists:the contents of the report of the characteristics of a complex intervention is more a lack of research, lack of theoretical schemes formation mechanism of action is not enough analysis, complex intervention advantage account is not clear and so on. The proposed report can help improve the comprehensiveness and accuracy of the report, the complex process of advancing medicine intervention studies to improve the quality of research.